Mirage ProPulse Irrigator Руководство пользователя

1

®

IRRIGATOR

REF PP17P

1

®

IRRIGATOR

REF PP17P

1

®

IRRIGATOR

REF PP17P

2 | en

2

®

Propulse ProScoop™

INS0040

®

Propulse Head Lamp

INS0036

®

Propulse Cleaning Tablets

(x200 per pack)

CL0001

®

Propulse QrX™ Single Use

Tip (x100 per pack)

KIT5002

®

Propulse ProTect™ Cape

KIT1012

®

Propulse Carry Case

KIT1005

3 | en

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INTENDED PURPOSE

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 

 

 

 

 



 

 

 

 

 



WARNINGS AND CAUTIONS

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  

 

 

 

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  

 

 





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 

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

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 

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 

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 

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 

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



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  

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 

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®

It is recommended that the Propulse Ear Irrigator is serviced annually

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  

4 | en

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®



Please note: Damage caused to your  Ear Irrigator by the use of accessories,

consumables or service agents not recommended by Mirage Health Group, will invalidate

your warranty.

DO NOT IRRIGATE























 

 

 

 

 

 

 

 

 

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COMPONENT / PARTS INDENTIFICATION



 

 

 

 

 

 

 

 



 

 



  

 

 

 

Please note





 

5 | en



TECHNICAL DATA



     

    

   

     

     

   

   

         

   

   

    

    





IPX1





















GUIDE TO SYMBOLS

I

O



















6 | en



OPERATING INSTRUCTIONS





 

 

 

 prior to ﬁrst use

 

 

 

 

 

 

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  

 

 

 

 

 

 

 

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  

 and

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  every prior

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

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 

 

 

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  



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



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OPERATING INSTRUCTIONS





 

 

 

 prior to ﬁrst use

 

 

 

 

 

 

 

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  

 

 

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

  

 and

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 

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 

 

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

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  

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

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

7 | en

7

®

1) Remove the reservoir from the Propulse Ear Irrigator.

2) Remove the old Mushroom Valve from the reservoir and discard

3) Insert a new Mushroom Valve without bending or exer�ng undue force on the legs of the

Mushroom Valve, into the reservoir.

4) Check the condi�on of the ‘O’ ring on the base of the reservoir and if worn replace with a new

unit speciﬁc ‘O’ ring.

5) Return the reservoir to the machine

DETAILED INFORMATION

Fi�ng the Footswitch

The footswitch is connected to the main unit by a socket in the side of the device. The

®

Propulse

®

Propulse Ear Irrigator will NOT operate unless the footswitch is connected.

Filling the water reservoir

It is recommended that:

i) The water reservoir is removed from the device for ﬁlling and that the lid is always in place when

the water container is in-situ on the device.

ii) The water reservoir should be ﬁlled to the horizontal line on the front. This helps to eliminate the

risk of spillage.

iii) Water at 40°C is recommended. Higher temperatures increase the risk of scalding and burns to

the pa�ent. Lower temperatures increase the risk of pa�ent discomfort and dizziness.

®

Fi�ng the Propulse QrX™ Tip

® ®

The Propulse Ear Irrigator is designed to be used only with Propulse QrX™ Single Use Tips.

®

Use one Pr

opulse QrX™ Tip per treatment.

®

To ﬁt a Propulse QrX™ Tip

1) Remove Tip from packaging - Tips are non-sterile.

2) Push Tip into Handle un�l a click can be heard.

®

To remove a Propulse QrX™ Tip

1) Retract the QrX™ Locking Collar using a thumb.

2) Grasp the used QrX™ Tip between foreﬁnger and thumb and pull gently from the QrX™ Handle.

3) Dispose of the used Tip in accordance with local authority guidelines. DO NOT REUSE TIPS.

®

Propulse QrX™ Tips are available to purchase in boxes of 100 individually wrapped (non-sterile)

® ®

�ps from your normal Propulse supplier or from Mirage directly (UK only). Propulse QrX™ Tips

® ®

are clearly branded with the Propulse logo on the �p and its packaging. Only branded Propulse

®

QrX™ Tips should be used with the Propulse Ear Irrigator.

Replacing the Mushroom Valve

The Mushroom Valve is speciﬁcally designed to prevent water ﬂowing out of the reservoir whilst

ﬁlling. Should a replacement Mushroom Valve be required, please follow the steps below -



 .

This will help prevent possible damage to the water inlet valve.

8 | en

8

Guidance and Manufacturer’s Declaration – Electromagnetic emissions

The Propulse is intended for use in the electromagnetic environment specified below. The customer

or user of the Propulse should assure that it is used in such an environment.

Emission tests Compliance Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1 The Propulse uses only energy for its internal function.

Therefore, its RF emissions are not likely to cause any

interference in nearby electronic equipment.

RF emissions

CISPR 11

Class A The Propulse is suitable for use in all establishments

other than domestic and those directly connected to the

public low-voltage power supply network that supplies

buildings used for domestic purposes.

Harmonic

emissions IEC

61000-3-2

Class A

Voltage

fluctuation/flicker

emissions IEC

61000-3-3

Complies

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

The Propulse is intended for use in the electromagnetic environment specified below. The customer

or the user of the Propulse should assure that it is used in such an environment

Immunity test IEC 60601 test level Compliance level Electromagnetic environment -

guidance

Electrostatic

discharge (ESD) IEC

61000-4-2

6 kV contact

8 kV air

6 kV contact

8 kV air

Floors should be wood, concrete

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be at

least 30%.

Electrical fast

transient/ burst

IEC 61000-4-4

2 kV for power

supply lines

1 kV for

input/output lines

2 kV for power

supply lines

Not applicable

Mains power quality should be

that of a typical commercial or

hospital environment.

Surge

IEC 61000-4-5

1 kV differential

mode

2 kV common

mode

1 kV differential

mode

2 kV common

mode

Mains power quality should be

that of a typical commercial or

hospital environment.

Voltage dips, short

interruptions and

voltage variations

on

power supply input

lines

IEC 61000-4-11

< 5 % UT (> 95 %

dip in UT) for 0.5

cycle 40 % UT (60

% dip in UT) for 5

cycles 70 % UT (30

% dip in UT) for 25

cycles

< 5 % UT (> 95 %

dip in UT) for 5 s

< 5 % UT (> 95 %

dip in UT) for 0.5

cycle 40 % UT (60

% dip in UT) for 5

cycles 70 % UT

(30 % dip in UT)

for 25 cycles

< 5 % UT (> 95 %

dip in UT) for 5 s

Mains power quality should be

that of a typical commercial or

hospital environment. If the user

of the Propulse requires

continued operation during power

mains interruptions, it is

recommended that the Propulse

be powered from an

uninterruptible power supply or a

battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m Not applicable Power frequency magnetic fields

should be at levels characteristic

of a typical location in a typical

commercial or hospital

environment.

NOTE UT is the A.C. mains voltage prior to application of the test level.

9 | en

99

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Propulse is intended for the use in the electromagnetic environment specified below.

The customer or the user of the Propulse should assure that it is used in such an environment

Immunity test IEC 60601 test level Compliance

level

Electromagnetic environment – guidance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

3 Vrms

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2,5 GHz

3 V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the Propulse, including cables, than

the recommended separation distance

calculated from the equation applicable to

the frequency of the transmitter:

Recommended protection distance:

d = 1.17 vP

d = 1.17 vP for 80 MHz to 800 MHz

d = 2,3 vP for 800 MHz to 2.5 GHz

where P is the maximum output power rating

of the transmitter in watts (W) acc. To the

transmitter manufacturer and d is the

recommended separation distance in meters

(m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site

survey, a should be less than the compliance

level in each frequency range.

b

Interference

may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflections from structures, objects and people.

a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast

cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to

fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field

strength in the location in which the Propulse is used exceeds the applicable RF compliance level

above, the Propulse should be observed to verify normal operation. If abnormal performance is

observed, additional measures may be necessary, such as reorienting or relocating the Propulse.

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended Separation Distance between portable and mobile

RF Communications Equipment and the Propulse

The Propulse is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Propulse can help prevent

electromagnetic interference by maintaining minimum distance between portable and mobile RF

communications equipment (transmitters) and the Propulse as recommended below, according to

the maximum output power of the communications equipment.

Rated maximum

output power of

transmitter (W)

Separation distance according to the transmit frequency

(m)

150 kHz to 80 MHz

d = 1.17 v P

80 MHz to 800 MHz

d = 1.17 v P

800 MHz to 2,5 GHz

d = 2.33 v P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23.

For transmitters rated at a maximum output power not listed above, the recommended separation

distance d in meters (m) can be estimated using the equation applicable to the frequency of the

transmitter, where p is the maximum output power rating of the transmitter in watt (W) according

to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.